62856-535 : Belviq XR Extended Release 20 mg Oral Tablet, Film Coated, Extended Release

NDC:	62856-535
Labeler:	Eisai Inc.
Product Type:	Human Prescription Drug
Drug Name:	Belviq XR Extended Release Extended Release
Dosage Form:	Oral Tablet, Film Coated, Extended Release
Application #:	NDA208524
Rev. Date:	Jul 15, 2016
CSA Schedule:	CIV (US) [1]

^[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:

Markings:	A;20
Shapes:	Round
Colors:	Orange
Size (mm):	9
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 62856-535-30: 1 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (62856‑535‑30)

Active Ingredients:

• Lorcaserin Hydrochloride Hemihydrate

Inactive Ingredients:

• Hypromellose 2910 (15 Mpa.s)
• Cellulose, Microcrystalline
• Mannitol
• Hypromellose 2208 (4000 Mpa.s)
• Ethylcelluloses
• Silicon Dioxide
• Polyvinyl Alcohol, Unspecified
• Polyethylene Glycols
• Titanium Dioxide
• Talc
• Fd&c Yellow No. 6
• Aluminum Oxide
• Ferric Oxide Yellow
• Ferric Oxide Red
• Magnesium Stearate

Pharmaceutical Classes:

• Serotonin-2c Receptor Agonist [EPC]
• Serotonin 2c Receptor Agonists [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]

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